Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

Last updated: November 19, 2024
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

1

Condition

Pancreatic Cancer

Pancreatic Disorders

Treatment

Therapeutic Colonoscopy

Resection

Questionnaire Administration

Clinical Study ID

NCT04975217
2020-0788
2020-0788
NCI-2021-03484
  • Ages > 18
  • All Genders

Study Summary

This early phase I trial examines the safety and effects of fecal microbial transplants in treating patients with pancreatic cancer. scheduled for surgery to remove tumors. Fecal microbial transplant contains the normal microbes found in fecal (stool) material. Giving fecal microbial transplant may help control the disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients that are seen at MD Anderson Cancer Center

  • Patients with pancreatic ductal adenocarcinoma (PDAC) diagnosis who are expected tohave surgery (Whipple)

  • Adequate hematological function, defined by white blood cell (WBC) count ≥ 3,000/microL, platelet count ≥75,000/microL, and Hgb ≥ 8 g/dL

  • Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limitof normal (ULN), an AST, level ≤ 2.5 × ULN, and an ALT level ≤ 2.5 × ULN

  • Adequate renal function defined by an estimated creatinine clearance >30 mL/minaccording to the Cockcroft-Gault formula or by a creatinine clearance measurementfrom a 24-hour urine collection

  • Age 18 years and above

  • Male or female

  • Willingness and ability to sign an informed consent

  • Consent and ability to give blood and stool samples

  • Consent to undergo a baseline core biopsy and colonoscopy for FMT delivery

  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion

Exclusion Criteria:

  • Age younger than 18 years

  • Positive GI infection

  • Patients with pancreatic cancer Stage T1N0

  • Individuals at higher risk of colonization with MDROs

  • Patient received antibiotics in the last 48 hours. Patients will be eligible toenroll if antibiotic therapy is discontinued for at minimum 48 hours prior to startof study

  • Patients with active viral, bacterial or fungal infection

  • History of inflammatory bowel disease, and/or radiation enteritis or colitis

  • Pregnant and breastfeeding women

  • Women of child-bearing potential who have positive urine or serum pregnancy test orrefuse to do pregnancy test

  • Has a diagnosis of immunodeficiency

  • Peripheral WBC >12 x 10^9/L and/or temperature >38 degrees Celsius

  • Subjects with neutropenia (ANC <1500)

  • Swallowing dysfunction or known chronic aspiration

  • Delayed gastric emptying

  • History of intestinal obstruction

  • Acute exacerbation of underlying comorbid condition

  • Severely immunocompromised patients

  • Allergies to drugs included as part of trial (antibiotics, loperamide or laxatives)

Study Design

Total Participants: 10
Treatment Group(s): 5
Primary Treatment: Therapeutic Colonoscopy
Phase: 1
Study Start date:
December 14, 2021
Estimated Completion Date:
December 31, 2026

Study Description

PRIMARY OBJECTIVE:

I. To assess the safety, tolerability, and feasibility of fecal microbiota transplantation (FMT) in resectable patients with pancreatic ductal adenocarcinoma (PDAC).

SECONDARY OBJECTIVES:

I. To assess changes in gut microbiome of PDAC patients after FMT. II. To assess changes in oral microbiome of PDAC patients after FMT. III. To assess changes in tumor microbiome of PDAC patients after FMT. IV. To determine immunological/molecular changes in the tumor after FMT.

OUTLINE:

Patients undergo FMT during colonoscopy. Patients also receive FMT capsules orally (PO) once weekly (QW) for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care resection of tumor(s).

After completion of study treatment, patients are followed up at 2 weeks and 30, 60, 90, and 180 days after surgery.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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